Evaluation of Ibuprofen Versus Conventional Analgesic Therapy in Acute Myocarditis with Preserved Left Ventricular Ejection Fraction

The primary objective of this study is to evaluate the **utility** of ibuprofen therapy for a duration of 3 weeks compared to conventional treatment with analgesics, specifically paracetamol, in patients with acute myocarditis who have preserved left ventricular ejection fraction. The clinical relevance of this objective lies in its focus on reducing late gadolinium enhancement observed on cardiac magnetic resonance imaging at a 6-month follow-up. This outcome is significant as it may indicate a reduction in myocardial inflammation and potential improvement in cardiac function, which are critical factors in the management of acute myocarditis.

The clinical trial focuses on individuals diagnosed with **acute myocarditis**. The study population includes both male and female participants aged 18 years or older. Participants are required to have been hospitalized for confirmed acute myocarditis with a preserved left ventricular ejection fraction of 50% or greater. The trial excludes individuals with acute heart failure or ischemic heart disease. Participants must meet diagnostic criteria for myocarditis as determined by cardiac magnetic resonance imaging and must be capable of providing informed consent. The sponsor has not provided information regarding the total number of participants. The trial does not specifically target a vulnerable population, and no particular lifestyle considerations such as diet or physical activity are highlighted in the selection criteria.

The clinical trial is designed to evaluate the efficacy of **ibuprofen** therapy compared to conventional treatment with analgesics, specifically paracetamol, in patients with **acute myocarditis** and preserved left ventricular ejection fraction. This study is structured as a randomized, double-blind, controlled trial, ensuring that neither the participants nor the researchers know which treatment the participants are receiving, thereby minimizing bias. The trial is categorized as a low-intervention study and is expected to span from September 2024 to January 2027, with the primary endpoint being the change in late gadolinium enhancement on cardiac magnetic resonance imaging at a 6-month follow-up.

Participants will undergo a series of study visits, beginning with an inclusion visit where eligibility is confirmed based on criteria such as age (18 years or older), confirmed diagnosis of acute myocarditis, and the ability to provide informed consent. The absence of acute heart failure and exclusion of ischemic heart disease are also required. Following the inclusion visit, participants will be randomly assigned to receive either ibuprofen or paracetamol for a treatment period of 3 weeks. Follow-up visits will be scheduled to monitor the participants' health status and adherence to the treatment protocol. The end-of-study visit will occur at the 6-month mark, where the primary endpoint will be assessed.

The expected length of participant involvement is approximately 6 months, from the initial screening to the final assessment. Conditions that may lead to early termination from the study include the development of acute heart failure, significant adverse reactions to the study medication, or withdrawal of consent by the participant. The study aims to provide valuable insights into the management of acute myocarditis, potentially influencing future therapeutic approaches.

The clinical trial involves the use of **ibuprofen** as the experimental medication. Ibuprofen is administered in the form of a **tablet** and is taken **orally**. The maximum daily dose of ibuprofen is **1800 mg**, with a total maximum dose of **25200 mg** over the course of the treatment period. The treatment duration is set for a maximum of **3 weeks**. The primary objective of the trial is to evaluate the efficacy of ibuprofen therapy in patients with acute myocarditis, specifically in reducing late gadolinium enhancement on cardiac magnetic resonance imaging at a 6-month follow-up.

In addition to the experimental treatment, the study includes a comparator treatment using **paracetamol**, which serves as the conventional treatment. Paracetamol is used as an analgesic in this trial to provide a standard-of-care therapy for participants. The administration details, including dosage and frequency for paracetamol, are aligned with standard medical guidelines for analgesic use in acute myocarditis. Participant compliance with the medication regimen is monitored throughout the study to ensure adherence to the prescribed dosing schedules.

Efficacy in the clinical trial titled "Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) versus Conventional Treatment in Acute Myocarditis" will be assessed by evaluating the primary endpoint, which is the change in late gadolinium enhancement measured as a percentage relative to indexed myocardial mass. This assessment will be conducted using cardiac magnetic resonance imaging (MRI) at baseline, upon admission, and at a 6-month follow-up after diagnosis. The trial aims to compare the efficacy of **ibuprofen** therapy administered for 3 weeks against conventional treatment with analgesics, specifically paracetamol, in patients with acute myocarditis who have preserved left ventricular ejection fraction.